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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Mamma Mia Italian, Wall Street Northwest, Abingdon, VA, USA

Total all time reports:  1
Latest report: March 18, 2020 6:00 PM
My mother and I after eating here, Mamma Mia Italian, Wall Street Northwest, Abingdon, VA, USA

My mother and I after eating here

Symptoms: Other

March 18, 2020 6:00 PM

“An infected owner of pizzeria. He made out food and was very sick Mother and I Went in there on February 25th around 3 pm. Restaurant was very empty. Ordered pizza and the owner came out and asked how foo ... See Mored was, we exchanged small talk and he told us about his cooking school family members own in France. He was NOTABLY SICK sniffing and trying to suppress cough. 3 days later my elderly mother started getting sore throat, cough, stuffy nose. Full blown sick. She went 2 x to doctors they sent her home with very strong antibiotics. The following week March 6th I was full blown sick. Same symptoms. I truly believe my mother and I were exposed to corona virus from this experience See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

June 23, 2020 8:01 PM

“Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling fou ... See Morer (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

No illnesses have been reported to date in connection with this problem.

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 20, 2020 11:38 AM

“Uber Eats, one of your restaurants, is putting your customer's health at risk. This was 50 euros and most of the order was missing, thankfully. Bloody raw chicken in open paper bags. Filthy See Less
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Flat out raw chicken, Arby's, 14020 23 Mile Road, Shelby, MI 48315, USA

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April 15, 2020 8:00 PM

“Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is volunt ... See Morearily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 28, 2020 5:32 PM

“Company name: Apotex Corp
Brand name: Apotex Corp
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: May 28, 2020
Recall details: Apotex Corp is voluntarily recalling all lots ... See Moreof Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US.

Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

- Product: Metformin Hydrochloride Extended-Release Tablets, USP
- Strength: 500mg
- Pack Size: 100's Bottle
- NDC Number: 60505-0260-1

The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

August 1, 2020 5:01 PM

“Company name: Laboratorios Jaloma S.A. de C.V.
Brand name: Jaloma
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: August 01, 2020
Recall details: LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma An ... See Moretiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclared methanol (wood alcohol). Although the contamination was linked to the 500 mL product, due to the abundance of caution, Jaloma is recalling all lots of all sizes within expiry. The NDCs, lot #s, and expiration dates are listed in the table below.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, LABORATORIOS JALOMA S.A. de C.V. has not received any reports of adverse events related to this recall.

Recalled Products:

-Product(s): Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% With vitamin E
-NDCs: 65055-600-02
-Sizes: 16.9 fl oz. (1.06 pt) (500 mL)
-UPC: 7 59684 51503 3
-Lot #s & Expiration Dates: 0005295 Exp: April, 2022 / 0006373 Exp: May, 2022

-Product(s): Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% With vitamin E
-NDCs: 65055-600-01
-Sizes: 4 fl oz (120 mL)
-UPC: 7 59684 51502 6
-Lot #s & Expiration Dates: 0005412 Exp: April, 2022 / 0007134 Exp: May, 2022 / 0007834
-Exp: May, 2022 / 0009239 Exp: June, 2022

The product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The products are distributed in a 4 fl oz (120 mL) Polyethylene Terephthalate (PET) plastic bottle and a 16.9 fl oz (1.06 pt) (500 mL) PET or High-density polyethylene (HDPE) plastic bottle. Product is labeled with a red logo with the word Jaloma written in white letters. The product was distributed throughout the United States. It was imported to one (1) wholesaler and two (2) distributors.

Each product contains a lot number and expiration date stamped directly on the bottle or on the label of the 16.9 fl oz HDPE bottle in the format below. See table for lot numbers of each individual bottle.

0007834 EXP0522

LABORATORIOS JALOMA S.A. de C.V. is notifying its customers/distributors by recall letter and consumers via this press release. LABORATORIOS JALOMA S.A. de C.V.is arranging for return and refund of all recalled products.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 28, 2020 2:00 AM

“Company name: Resource Recovery & Trading, LLC
Brand name: Resource Recover & Trading, LLC
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol subpotency ethyl alcohol
FDA Recall date: July 27, 2020
Recall details: RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling ... See Moreall the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.

Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer to decrease germs when soap and water is not available and is packaged in 200 ml plastic bottles and 20 liter plastic containers. The product can be identified by the label attached. The product was distribution between June 10, 2020 and June 20, 2020 in the states of Alabama and Georgia.

RESOURCE RECOVERY & TRADING LLC is notifying its distributors and customers by phone calls and emails and is arranging for return and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 7, 2020 3:00 PM

“Company name: Mylan Institutional LLC
Brand name: Mylan
Product recalled: Daptomycin for Injection
Reason of the recall: Presence of particulate matter
FDA Recall date: July 07, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is ... See Moreconducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.

Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:

- NDC #: 67457-813-50
- Material Description: Daptomycin for Injection
- Strength: 500 mg/vial
- Size: 20 mL vial
- Lot No: 7605112
- Expiry: October 2021

Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 20, 2020 4:00 PM

“Company name: Fresenius Kabi USA, LLC
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL
Reason of the recall: Presence of Particulate Matter
FDA Recall date: April 20, 2020
Recall details: Freseni ... See Moreus Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen, and polyamides.

Particulate matter was found in eight reserve sample vials. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

- Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial. NDC: 63323-162-01. Product code: 160201. (Check the recall notice for specific batch numbers)
- Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial. NDC: 63323-162-02. Product code: 160202. (Check the recall notice for specific batch numbers)

Check the full recalled product list and details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Symptoms, Cranston, RI, USA

Cranston, RI, USA

April 8, 2020 4:39 PM

“Headache, nasal congestion. Have not been around anyone in 3 weeks.....did not leave the house often at all expect the drive thru at Target and Gas. See Less
Reported By SafelyHQ.com User